Requirements for quality stability of package materials The first chapter of chapter third of the "standard for the management of drug quality and production (revised in 2010)" stipulates that "this standard is the quality management of the standard." Part of the system is the basic requirement of drug production management and quality control, and it is aimed at... Ensure sustained and stable production of drugs that meet the intended use and registration requirements. " The second chapter, the sixth rule, "enterprise top management should ensure the achievement of the established quality goals. People of different levels, suppliers and distributors should participate in and undertake their respective responsibilities." In fact, the continuous and stable drug quality is the requirement for the quality of the drug production and the quality of the packaging material for the direct contact with the drug. This is because the quality of medicines depends on many factors, such as production technology, raw materials, packaging materials, production equipment and production environment. Among them, packaging materials directly contacting drugs are important factors. Moreover, in the "drug quality production management standard (2010 Revision)", the requirements for the management and control of the packaging materials for direct contact with drugs are the same as those of raw and auxiliary materials. In order to achieve this requirement, the pharmaceutical enterprises must decompose the responsibility, in which the quality responsibility of the pharmaceutical package is mainly undertaken by the pharmaceutical package enterprises.

The pharmaceutical packaging industry has accounted for 10% of the total output value of the domestic packaging, and now the market of pharmaceutical packaging is constantly developing. This is the internal driving force for the entire pharmaceutical bottle manufacturers. Plastic bottle packaging industry itself has its own advantages, so in the form of drug packaging industry constantly changing, from the original paper bags, plastic bags are polyethylene plastic bottles and polypropylene bottles and other forms such as plastic bottles, future hood packaging and packaging will also strip composite film become the mainstream of solid dosage forms of drug packaging. At the same time, the problem of plastic bottle quality has begun to attract attention from all walks of life, including the environmental protection and safety and health aspects of the quality of the products. In order to eliminate consumer environmental problems, pharmaceutical packaging enterprises have started from the green environmental protection as the starting point, design and production are: green packaging, packaging, recycling environmental regulation of high barrier packaging, aseptic packaging, antimicrobial packaging etc.. For the pharmaceutical bottle market, the market share of plastic medicine bottles has been rising in recent years. Due to some defects in the packaging honey, the market share of traditional glass medicine bottles is rapidly compressed, and the number of manufacturers engaged in glass bottles is far less than that of plastic bottles. With the rapid development of plastics industry and the continuous reform and innovation of technology, plastic packaging has great development potential in the pharmaceutical industry market, and is developing rapidly in China. In the next few years, the world's pharmaceutical packaging market will become the second pillar pillar of the plastic bottle packaging industry's economic growth. In China, it will also become the fastest growing pharmaceutical plastic bottle industry. After about five years, China will become the largest market for plastic plastic bottles in the world. The plastic industry so wide market will promote the continuous development of related industries, plastic pharmaceutical packaging will become an important driving force for the development of the pharmaceutical industry.

In recent years, the development of health care products packaging bottle industry very quickly, any packaging must according to the needs of the market design, after entering the industrial society, the market economy of the commodity cycle is shortened, the same is a property of the products, due to the increase of manufacturers, packaging is also playing the cultural characteristics, the company's market competition, price wars force businesses constantly updated products, constantly transform packaging. Health care products should be stored in a health care bottle, other reagents are generally used glass bottles, packaging materials with different properties and different functions in the production and packaging, health care bottle can fully play its role and value in use, the plastic bottle with certain material and performance are used to ensure dress material and material will not produce any changes and effect. The production technology of health care bottle: there are two main types: high pressure tube method and kettle type method. From the current development situation, in order to reduce the reaction temperature and pressure, tubular process commonly used high activity at low temperature initiator polymerization system with high purity ethylene as main raw materials, with propylene / propane as the density regulator, the use of high active initiator in about 200 to 330 DEG C, under the condition of 150-300MPa polymerization reaction. Health product bottle extrusion, also known as extrusion molding, is a method of extruding the heated resin continuously through the mold and extruding the desired shape products by extrusion molding machine. Extrusion is sometimes used in the molding of thermosetting plastics and can be used in the molding of foamed plastics. The advantage of extrusion is that it can squeeze out all kinds of products. It has high efficiency and automation and continuous production. The disadvantage is that thermosetting plastics can not be widely used in this process, and the size of products is easy to cause deviation.

1. History of plastic bottle development: In 1980s, as China continuously introduced advanced plastic bottle production lines from abroad, it opened the prelude to "plastic" instead of "glass". From that point, plastic bottles were widely used in the packaging field. The plastic bottle is mainly based on polymer non-toxic such as high density polyethylene (HDPE), polyester (PET), polypropylene (PP), polycarbonate (PC) as the main raw material, plastic molding process and equipment for producing all kinds of plastic bottles advanced, mainly containing various capsules, tablets, granules, powder, capsules, oral liquid solid and liquid etc.. Two. The use of plastic bottles: At present, most of the medicines, nutrition and health care products, food and drinks sold on the market are packed in plastic bottles. You can go anywhere in the drugstore or supermarket, and you can see products packed in plastic bottles everywhere. Medicines and nutritional health products are mainly used in PET bottles (PET bottles) and HDPE bottles (HDPE bottles). The main beverage is polyester bottle (PET), and daily necessities such as shampoo and shower gel are high density polyethylene bottles (HDPE bottles). The plastic bottle is the biggest characteristic of light weight, non friable, clean and beautiful, and some of its technical indicators and data show that the chemical properties of water vapor permeability, good sealing performance, it is entirely possible to shield and protect the safety of products within the validity period of the product. Three, choose the principle of plastic bottle: L plastic bottles, the choice of what materials to do, you must first meet the requirements of non-toxic, no smell, because of the main raw material variety, which requires the comprehensive performance of the material selection, the general selection of tablets of high density polyethylene, polypropylene bottles, such as the need for transparency can choose polyester bottle (PET bottle). Such as the need for higher barrier properties, and light resistance, opaque, with brown PET bottles, liquid dosage form drugs generally used in polypropylene bottles or PET bottles as the main raw materials. At present, the domestic nutritional and food packaging bottles are mainly made of PET or HPDE, and the cap of the bottle is PP 2, the seal of the bottle and cover, the permeability of water vapor. Sealing and water vapor permeability are two important technical indicators of plastic bottles. They play an important role in the stability of the packaged products. 3. The quality standard of plastic bottle products. The quality of the product can be analyzed and judged from the product quality standard of the production plant. 4. Quality assurance system. The audit of suppliers has become an essential part of the purchase of plastic bottles. Through the audit, we can make a comprehensive and correct assessment of the soft and hardware facilities, the technical equipment and the comprehensive quality of the production plant. 5, packaging for medicine, nutrition and health care products, food and beverage absolutely can not use recycled materials issued by the Ministry of health "food with plastic products and raw materials and health management measures" have clearly defined: "where the processing of plastic utensils, containers, food packaging materials, shall not use recycled plastic." The law was issued in November 26, 1990. Four. Status of plastic bottles

    The plastic packaging bottle has a beautiful appearance, which greatly improves the grade and brand image of the medicine. The PET bottle is one of the best choices for the users to clearly see the hygienic level and quality of the medicine in the bottle. Conlun Plastics Co., Ltd. has been improving continuously through plastic packaging. Just like the recent popular oral liquid with health and health care function at home and abroad, some manufacturers have changed the brand new packaging -- entering the market of modern youth, facing fierce competition. The old oral liquid is wrapped in glass bottle or opaque medicine bottle. When opening the glass bottle, it is troublesome and dangerous, and it is not good enough. Some of the bottle glass powder falls into the medicine, which makes the user feel uncomfortable. The same, opaque medicine bottle, the user can not see the quality of the drug completely, but also owes the sense of safety. Plastic bottles are suitable for high temperature sterilized drugs or oral liquids. They can improve the transparency, strength, hardness and gloss of plastic bottles, and combine their aesthetics and practicality, so that they will become the trend of the new generation of packaging methods. In addition to public medicine, general hospital for patient infusion (commonly known as glucose), has been almost completely used plastic bottles to replace the traditional glass bottles or soft packing bag, which cited the plastic bottle wholesale its not easy to be broken, high transparency, disposable, sanitary and convenient transportation of the advantages of the net.